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2.6 Stevia Leaf - Too Good To Be Legal?
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Rob McCaleb
Herb Research Foundation
For hundreds of years, people in Paraguay and Brazil have used a sweet
leaf to sweeten bitter herbal teas including mate. For nearly 20
years, Japanese consumers by the millions have used extracts of the
same plant as a safe, natural, non-caloric sweetener. The plant is
stevia, formally known as Stevia rebaudiana, and today it is under
wholesale attack by the U.S. Food and Drug Administration.
Stevia is a fairly unassuming perennial shrub of the aster family
(Asteraceae), native to the northern regions of South America. It has
now been grown commercially in Brazil, Paraguay, Uruguay, Central
America, the United States, Israel, Thailand and China. The leaves
contain several chemicals called glycosides, which taste sweet, but do
not provide calories. The major glycoside is called stevioside, and is
one of the major sweeteners in use in Japan and Korea. Stevia and its
extracts have captured over 40% of the Japanese market. Major
multinational food companies like Coca Cola and Beatrice foods,
convinced of its safety, use stevia extracts to sweeten foods for sale
in Japan, Brazil, and other countries where it is approved.
Europeans first learned of stevia when the Spanish Conquistadors of the
Sixteenth Century sent word to Spain that the natives of South America
had used the plant to sweeten herbal tea since "ancient times".
The saga of American interest in stevia began around the turn of the
Twentieth Century when researchers in Brazil started hearing about "a
plant with leaves so sweet that a part of one would sweeten a whole
gourd full of mate." The plant had been described in 1899 by
Dr. M. S. Bertoni. In 1921 the American Trade Commissioner to Paraguay
commented in a letter "Although known to science for thirty years and
used by the Indians for a much longer period nothing has been done
commercially with the plant. This has been due to a lack of interest
on the part of capital and to the difficulty of cultivation."
Dr. Bertoni wrote some of the earliest articles on the plant in 1905
and 1918. In the latter article he notes:
"The principal importance of Ka he'e (stevia) is due to the possibility
of substituting it for saccharine. It presents these great advantages
over saccharine:
1. It is not toxic but, on the contrary, it is healthful, as shown
by long experience and according to the studies of Dr. Rebaudi.
2. It is a sweetening agent of great power.
3. It can be employed directly in its natural state, (pulverized
leaves).
4. It is much cheaper than saccharine."
Unfortunately, this last point may have been the undoing of stevia.
Noncaloric sweeteners are a big business in the U.S., as are caloric
sweeteners like sugar and the sugar-alcohols, sorbital, mannitol and
xylitol. It is small wonder that the powerful sweetener interests
here, do not want the natural, inexpensive, and non-patentable stevia
approved in the U.S.
In the 1970s, the Japanese government approved the plant, and food
manufacturers began using stevia extracts to sweeten everything from
sweet soy sauce and pickles to diet Coke. Researchers found the
extract interesting, resulting in dozens of well-designed studies of
its safety, chemistry and stability for use in different food products.
Various writers have praised the taste of the extracts, which has much
less of the bitter aftertaste prevalent in most noncaloric sweeteners.
In addition to Japan, other governments have approved stevia and
stevioside, including those of Brazil, China and South Korea, among
others. Unfortunately, the US was destined to be a different story.
Stevia has been safely used in this country for over ten years, but a
few years ago, the trouble began.
FDA ATTACK ON STEVIA
Around 1987, FDA inspectors began visiting herb companies who were
selling stevia, telling them to stop using it because it is an
"unapproved food additive". By mid 1990 several companies had been
visited. In one case FDA's inspector reportedly told a company
president they were trying to get people to stop using stevia "because
Nutra Sweet complained to FDA." The Herb Research Foundation(HRF),
which has extensive scientific files on stevia, became concerned and
filed a Freedom of Information Act request with FDA for information
about contacts between Nutra Sweet and FDA about stevia. It took over
a year to get any information from the FDA, but the identity of the
company who prompted the FDA action was masked by the agency.
In May, 1991 FDA acted by imposing an import alert on stevia to
prevent it from being imported into the US. They also began formally
warning companies to stop using the "illegal" herb.
By the beginning of 1991, the American Herbal Products Association
(AHPA) was working to defend stevia. At their general meeting at
Natural Products Expo West, members of the industry pledged most of
the needed funds to support work to convince FDA of the safety of
stevia. AHPA contracted HRF to produce a professional review of the
stevia literature. The review was conducted by Doug Kinghorn, PhD.,
one of the world's leading authorities on stevia and other natural
non-nutritive sweeteners. Dr. Kinghorn's report was peer-reviewed by
several other plant safety experts and concluded that historical and
current common use of stevia, and the scientific evidence all support
the safety of this plant for use in foods. Based on this report, and
other evidence, AHPA filed a petition with FDA in late October asking
FDA's "acquiescence and concurrence" that stevia leaf is exempt from
food additive regulations and can be used in foods.
FDA, apparently attempting to regulate this herb as they would a new
food additive, contends that there is inadequate evidence to approve
stevia. However, because of its use in Japan, there is much more
scientific evidence of stevia's safety than for most foods and
additives. The extent of evidence FDA is demanding for the approval
of stevia, far exceeds that which has been required to approve even
new synthetic food chemicals like aspartame (Nutra Sweet).
AHPA's petition points out that FDA's food additive laws were meant to
protect consumers from synthetic chemicals added to food. FDA is
trying, in the case of stevia to claim that stevia is the same as a
chemical food additive. But as the AHPA petition points out,
Congress did not intend food additive legislation to regulate natural
constituents of food itself. In fact, Congressman Delaney said in
1956, "There is hardly a food sold in the market today which has not
had some chemicals used on or in it at some stage in its production,
processing, packaging, transportation or storage." He stressed that
his proposed bill was to assure the safety of "new chemicals that are
being used in our daily food supply," and when asked if the
regulations would apply to whole foods, he replied "No, to food
chemicals only." AHPA contends that stevia is a food, which is
already recognized as safe because of its long history of food use.
Foods which have a long history of safe use are exempted by law from
the extensive laboratory tests required of new food chemicals. The
AHPA petition, however, supports the safe use of stevia with both the
historical record, and references to the numerous toxicology studies
conducted during the approval process in Japan, and studies by
interested researchers in other countries.
To date, the FDA still refuses to allow stevia to be sold in the U.S.
but the recently-enacted Dietary Supplement Health and Education Act
of 1994 may prevent the FDA from treating stevia and other natural
herbs as "food additives."
rmccaleb@herbs.org -- [also herbal@netcom.com]